Sandbox spb2013

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

2013 ESA Guidelines for the Management of Severe Perioperative Bleeding (DO NOT EDIT)

Acute Upper Gastrointestinal Bleeding

Class 1

"1. We recommend that acute variceal bleeding should be managed by a multidisciplinary team. A specific multimodal protocol for upper gastrointestinal hemorrhage should be available. (Level of Evidence: C)"

"2. We recommend that early treatment involves immediate use of vasopressors (somatostatin or terlipressin) to reduce bleeding and early interventional endoscopy. Antibiotics must be started on admission. (Level of Evidence: A)"

"3. rFVIIa should be used only as rescue therapy; we recommend against its routine use. (Level of Evidence: C)"

Coagulopathy and Renal Disease

Class 2

"1. We suggest that conjugated estrogen therapy should be used in uremia. (Level of Evidence: C)"

"2. We suggest that desmopressin should be considered for reducing bleeding during surgery and for managing acute bleeding in uremic patients. (Level of Evidence: C)"

Pediatric Surgery

Class 1

"1. We recommend against the use of rFVIIa in children. (Level of Evidence: C)"

Class 2

"1. We suggest the use of perioperative coagulation analysis using viscoelastic point-of-care monitoring (ROTEM/TEG) for timely detection of coagulation defects including dilutional coagulopathy and hyperfibrinolysis. (Level of Evidence: C)"

"2. We suggest that a critical hemoglobin threshold of 8 g/dl for RBC transfusion may be safe in severe pediatric perioperative bleeding. (Level of Evidence: C)"

"3. We suggest that transfusion of platelet concentrates may be considered if platelet count is <50,000–100,000/µl. (Level of Evidence: C)"

"4. We suggest that fibrinogen concentrate (30–50 mg/kg) or cryoprecipitate (5 ml/kg) may be used to increase plasma fibrinogen concentrations above trigger values of 1.5–2.0 g/l or FIBTEM MCF > 7 mm in bleeding children. (Level of Evidence: C)"

"5. We suggest that FFP may be used if no other fibrinogen source is available. (Level of Evidence: C)"

"6. We suggest against the routine use of desmopressin in the absence of hemophilia A or mild von Willebrand disease. (Level of Evidence: C)"

"7. We suggest that perioperative antifibrinolytic therapy should be used to reduce blood loss and transfusion requirements in cardiac and non-cardiac pediatric surgery. (Level of Evidence: A)"

Antiplatelet Agents

Class 1

"1. We recommend that aspirin therapy should continue perioperatively in most surgical settings, especially cardiac surgery. (Level of Evidence: C)"

"2. Where aspirin withdrawal is considered, we recommend a time interval of 5 days. (Level of Evidence: C)"

"3. Clopidogrel increases perioperative bleeding. In cases of increased bleeding risk, we recommend that it should be withdrawn for no more than 5 days. (Level of Evidence: C)"

"4. Prasugrel increases perioperative bleeding. In cases of increased bleeding risk, we recommend that it should be withdrawn for no more than 7 days. (Level of Evidence: C)"

"5. We recommend that antiplatelet agent therapy should resume as soon as possible postoperatively to prevent platelet activation. (Level of Evidence: C)"

"6. We recommend postponement of elective surgery following coronary stenting (at least 6 to 12 weeks for bare metal stent and one year for drug-eluting stents). (Level of Evidence: C)"

"7. We recommend that a multidisciplinary team meeting should decide on the perioperative use of antiplatelet agents in urgent and semi-urgent surgery. (Level of Evidence: C)"

Class 2

"1. For intra- or postoperative bleeding clearly related to aspirin, we suggest that platelet transfusion be considered (dose: 0.7 × 1011 [i.e. two standard concentrates] per 7 kg body weight in adults). (Level of Evidence: C)"

"2. We suggest that the first postoperative dose of clopidogrel or prasugrel should be given no later than 24 h after skin closure. We also suggest that this first dose should not be a loading dose. (Level of Evidence: C)"

"3. We suggest that urgent or semi-urgent surgery should be performed under aspirin/clopidogrel or aspirin/prasugrel combination therapy if possible, or at least under aspirin alone. (Level of Evidence: C)"

"4. We suggest that platelet transfusion should be considered (dose: 0.7 × 1011 [i.e. two standard concentrates] per 7 kg body weight in adults) in cases of intra- or postoperative bleeding clearly related to clopidogrel or prasugrel. (Level of Evidence: C)"

"5. According to pharmacological characteristics, we suggest that the management of ticagrelor may be comparable to clopidogrel (i.e. withdrawal interval of 5 days). (Level of Evidence: C)"

"6. Platelet transfusion may be ineffective for treating bleeding clearly related to ticagrelor when given 12 h before. (Level of Evidence: C)"

Heparin

Class 1

"1. We recommend that severe bleeding associated with intravenous unfractionated heparin (UFH) should be treated with intravenous protamine at a dose of 1 mg per 100 IU UFH given in the preceding 2–3 h. (Level of Evidence: A)"

Class 2

"1. We suggest that severe bleeding associated with subcutaneous UFH unresponsive to intravenous protamine at a dose of 1 mg per 100 IU UFH could be treated by continuous administration of intravenous protamine, with dose guided by aPTT. (Level of Evidence: C)"

"2. We suggest that severe bleeding related to subcutaneous low molecular weight heparin (LMWH) should be treated with intravenous protamine at a dose of 1 mg per 100 anti-Xa units of LMWH administered. (Level of Evidence: C)"

"3. We suggest that severe bleeding associated with subcutaneous LMWH and unresponsive to initial administration of protamine could be treated with a second dose of protamine (0.5 mg per 100 anti-FXa units of LMWH administered). (Level of Evidence: C)"

Fondaparinux

Class 2

"1. We suggest that the administration of rFVIIa could be considered to treat severe bleeding associated with subcutaneous administration of fondaparinux (off-label treatment). (Level of Evidence: C)"

Vitamin K Antagonists

Class 1

"1. We recommend that vitamin K antagonists (VKAs) should not be interrupted for skin surgery, dental and other oral procedures, gastric and colonic endoscopies (even if biopsy is scheduled, but not polypectomy), nor for most ophthalmic surgery (mainly anterior chamber, e.g. cataract), although vitreoretinal surgery is sometimes performed in VKA treated patients. (Level of Evidence: C)"

"2. We recommend that for low-risk patients (e.g. atrial fibrillation patients with CHADS2 score <=2, patients treated for > 3 months for a non-recurrent VTE) undergoing procedures requiring INR <1.5, VKA should be stopped 5 days before surgery. No bridging therapy is needed. Measure INR on the day before surgery and give 5 mg oral vitamin K if INR exceeds 1.5. (Level of Evidence: C)"

"3. We recommend bridging therapy for high-risk patients (e.g. atrial fibrillation patients with a CHADS2 score > 2, patients with recurrent VTE treated for <3 months, patients with a mechanical valve). Day 5: last VKA dose; Day 4: no heparin; Days 3 and 2: therapeutic subcutaneous LMWH twice daily or subcutaneous UFH twice or thrice daily; Day 1: hospitalisation and INR measurement; Day 0: surgery. (Level of Evidence: C)"

"4. We recommend that for groups 1 and 2 above, VKAs should be restarted during the evening after the procedure. Subcutaneous LMWH should be given postoperatively until the target INR is observed in two measurements. (Level of Evidence: C)"

"5. We recommend that for group 3 above, heparin (UFH or LMWH) should be resumed 6–48 h after the procedure. VKA can restart when surgical hemostasis is achieved. (Level of Evidence: C)"

"6. We recommend that, in VKA treated patients undergoing an emergency procedure or developing a bleeding complication, PCC (25 IU FIX/kg) should be given. (Level of Evidence: B)"

"7. We recommend to assess creatinine clearance in patients receiving NOAs and being scheduled for surgery. (Level of Evidence: B)"

New Oral Anticoagulants

Class 1

"1. We recommend that for low-risk patients (e.g. atrial fibrillation patients with CHADS2 score 2, patients treated for >3 months for a non-recurrent VTE) undergoing procedures requiring normal coagulation (normal diluted thrombin time or normal specific anti-FXa level), NOAs can be stopped 5 days before surgery. No bridging is needed. (Level of Evidence: C)"

Class 2

"1. We suggest that new oral anticoagulant agents (NOAs) should not be interrupted for skin surgery, dental and other oral procedures, gastric and colonic endoscopies (even if biopsy is scheduled, but not polypectomy), nor for most ophthalmic surgery, (mainly anterior chamber, e.g. cataract), although vitreoretinal surgery is sometimes performed in NOA treated patients. (Level of Evidence: C)"

"2. In patients treated with rivaroxaban, apixaban, edoxaban and in patients treated with dabigatran in which creatinine clearance is higher than 50 ml/min, we suggest bridging therapy for high-risk patients (e.g. atrial fibrillation patients with a CHADS2 score >2, patients with recurrent VTE treated for <3 months). Day 5: last NOA dose; Day 4: no heparin; Day 3: therapeutic dose of LMWH or UFH; Day 2: subcutaneous LMWH or UFH; Day 1: last injection of subcutaneous LMWH (in the morning, i.e. 24 h before the procedure) or subcutaneous UFH twice daily (i.e. last dose 12 h before the procedure), hospitalisation and measurement of diluted thrombin time or specific anti-FXa; Day 0: surgery. (Level of Evidence: C)"

"3. In patients treated with dabigatran with a creatinine clearance between 30 and 50 ml/min, we suggest to stop NOAs 5 days before surgery with no bridging. (Level of Evidence: C)"

"4. We suggest that for groups 2 and 3, heparin (UFH or LMWH) should be restarted 6–72 h after the procedure, taking the bleeding risk into account. NOAs may be resumed when surgical bleeding risk is under control. (Level of Evidence: C)"

Comorbidities Involving Hemostatic Derangement

Class 1

"1. We do not recommend discontinuation of Gingko biloba extracts. (Level of Evidence: B)"

Class 2

"1. We suggest that patients with hemostatic derangements associated with systemic, metabolic and endocrine diseases should be managed perioperatively in collaboration with a hematologist. (Level of Evidence: C)"

"2. We suggest that selective serotonin reuptake inhibitor (SSRI) treatment should not be routinely discontinued perioperatively. (Level of Evidence: B)"

"3. We suggest individualised perioperative discontinuation of antiepileptic agents, such as valproic acid, which may increase bleeding. (Level of Evidence: C)"

von Willebrand Disease

Class 1

"1. We recommend the use of bleeding assessment tools for predicting the perioperative risk of bleeding. (Level of Evidence: C)"

"2. We recommend that patients with VWD be managed perioperatively in collaboration with a hematologist. (Level of Evidence: C)"

"3. We recommend desmopressin as a first-line treatment for minor bleeding/surgery in patients with VWD, after a trial testing. The regimen is specified by published guidelines. (Level of Evidence: C)"

"4. We recommend replacement of VWF with plasma-derived products for major bleeding/surgery. Treatment regimens are specified by published guidelines. (Level of Evidence: C)"

Class 2

"1. We suggest that if VWD is suspected preoperatively, the patient be referred to a hematologist for assessment and planning of the intervention. (Level of Evidence: C)"

"2. We suggest that antifibrinolytic drugs be used as hemostatic adjuncts. Treatment regimens are specified by published guidelines. (Level of Evidence: C)"

"3. We suggest that platelet transfusion may be used only in case of failure of other treatments. (Level of Evidence: C)"

Platelet Defects

Class 1

"1. We recommend the use of a bleeding assessment tool for predicting the perioperative risk of bleeding. (Level of Evidence: C)"

"2. We recommend that patients with severe inherited platelet disorders should be managed perioperatively in collaboration with a hematologist. (Level of Evidence: C)"

"3. We recommend that rFVIIa treatment should be considered in patients with Glanzmann thrombasthenia undergoing surgery. (Level of Evidence: C)"

"4. We recommend against routine platelet transfusion in patients with inherited platelet disorders. (Level of Evidence: C)"

Class 2

"1. We suggest referring the patient to a hematologist for assessment and planning of the intervention if inherited platelet defects are suspected preoperatively. (Level of Evidence: C)"

"2. We suggest preoperative hemostatic correction in patients with inherited platelet disorders. (Level of Evidence: C)"

"3. We suggest desmopressin be used to prevent/control perioperative bleeding in patients with inherited platelet defects. (Level of Evidence: C)"

"4. We suggest antifibrinolytic drugs be used as hemostatic adjuncts in procedures involving patients with inherited platelet defects. (Level of Evidence: C)"

Hemophilia A and B

Class 1

"1. We recommend that hemophilia patients should be referred preoperatively to a hematologist for assessment/intervention. (Level of Evidence: C)"

"2. We recommend that surgery in hemophilia patients should be performed in specialised centres with expertise in coagulation disorders. (Level of Evidence: C)"

"3. We recommend adequate perioperative replacement therapy to ensure safe surgery in hemophilia patients. (Level of Evidence: C)"

"4. We recommend either recombinant products or plasma-derived concentrates for perioperative replacement therapy in hemophilia patients. (Level of Evidence: C)"

Class 2

"1. We suggest that perioperative replacement therapy (target factor level and duration) in hemophilia patients follows published guidelines. (Level of Evidence: C)"

"2. We suggest that coagulation factors be given perioperatively by continuous infusion. (Level of Evidence: C)"

"3. We suggest either rFVIIa or activated PCCs for hemophilia patients with inhibitors. (Level of Evidence: C)"

"4. We suggest antifibrinolytic drugs as perioperative adjunct therapy in hemophilia patients. (Level of Evidence: C)"

"5. We suggest individualized perioperative thromboprophylaxis in hemophilia patients. (Level of Evidence: C)"

Rare Bleeding Disorders

Class 1

"1. We recommend that patients with rare bleeding disorders should be referred preoperatively to a hematologist for assessment/intervention. (Level of Evidence: C)"

"2. We recommend that surgery in patients with rare bleeding disorders should be carried out in consultation with a hematologist with experience in factor deficiencies. (Level of Evidence: C)"

Class 2

"1. We suggest that rFVIIa be used in perioperative bleeding due to inherited FVII deficiency. (Level of Evidence: C)"

"2. If rFVIIa is given to control perioperative bleeding in inherited FVII deficiency, we suggest lower doses than in hemophilia patients. (Level of Evidence: C)"

Sources

• 2013 ESA Guidelines for the Management of Severe Perioperative Bleeding